drugset / Trial / NCT04182100

Efficacy and Safety of P1101 in Polycythemia Vera Patients for Whom the Standard of Treatment is Difficult to Apply

NCT04182100

Phase 2 Completed 29 enrolled PharmaEssentia Japan K.K.
NaSingle-groupOpen-labelTreatment

Summary

This is a Phase 2 single arm study to investigate efficacy and safety of P1101 for adult Japanese patients with PV.

Timeline

Start
2019-12-20
Primary completion
2021-03-08
Completion
2021-03-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Ropeginterferon alfa-2b Protein / enzyme biologic 50 ug Subcutaneous
Subject Ropeginterferon alfa-2b Protein / enzyme biologic 100 ug Subcutaneous
Subject Ropeginterferon alfa-2b Protein / enzyme biologic 500 ug Subcutaneous
Background Aspirin Small molecule 75 mg
Background Aspirin Small molecule 150 mg